A
ascherp
Hello,
It is not clear to us whether EMC testing according to IEC 60601-1-2 is appropriate for HF accessories. The specific device in question are insulated handle-shaft-insert modular instruments (laparoscopic forceps and dissectors) for electrosurgical coagulation.
According to European regulations, an HF accessory such as this is considered to be passive with regard to electromagnetic emissions. It is argued that the ESU generates the emissions, not the coagulation accessory. Testing according to IEC 60601-1-2 is not required for these instruments and none of approximately 10 manufacturers of HF accessories that I work with perform this type of testing.
Actually, Tables BB.1 and BB.2 of HF standard IEC 60601-2-2 indicate that, with all other factors (HF accessories, test set-up and protocol) being equal, there is a marked difference in the emmissions created by two different types of ESU. This seems to justify the standpoint that testing according to IEC 60601-1-2 would be appropriate for the ESU, not the accessory.
The FDA, on the other hand, is not clear about this issue. We have submitted three 510(k)s for different HF coagulation accessories over the last 15 months. The reviewers of two of those 510(k)s did not request EMC testing, the most recent one has.
So, as far as electrical safety is concerned (as opposed to the regulatory bodies' marketing authorization requirements), does it make sense to test HF accessories according to IEC 60601-1-2? And why (or why not)?
Thank you and kind regards.
It is not clear to us whether EMC testing according to IEC 60601-1-2 is appropriate for HF accessories. The specific device in question are insulated handle-shaft-insert modular instruments (laparoscopic forceps and dissectors) for electrosurgical coagulation.
According to European regulations, an HF accessory such as this is considered to be passive with regard to electromagnetic emissions. It is argued that the ESU generates the emissions, not the coagulation accessory. Testing according to IEC 60601-1-2 is not required for these instruments and none of approximately 10 manufacturers of HF accessories that I work with perform this type of testing.
Actually, Tables BB.1 and BB.2 of HF standard IEC 60601-2-2 indicate that, with all other factors (HF accessories, test set-up and protocol) being equal, there is a marked difference in the emmissions created by two different types of ESU. This seems to justify the standpoint that testing according to IEC 60601-1-2 would be appropriate for the ESU, not the accessory.
The FDA, on the other hand, is not clear about this issue. We have submitted three 510(k)s for different HF coagulation accessories over the last 15 months. The reviewers of two of those 510(k)s did not request EMC testing, the most recent one has.
So, as far as electrical safety is concerned (as opposed to the regulatory bodies' marketing authorization requirements), does it make sense to test HF accessories according to IEC 60601-1-2? And why (or why not)?
Thank you and kind regards.